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Friday, March 3, 2017

Nature: The liver
disease hepatitis C is the new battleground for lawsuits intended to
slash the cost of life-saving medicines. In February alone, five suits
were filed in India and Argentina claiming that the latest class of
antiviral drugs does not warrant the 20-year patent monopoly that
manufacturers have sought in those countries. In
the 2000s, successful challenges to patents on HIV drugs gave poor
nations access to high-quality ‘generic’ copies of the medications at
rock-bottom prices. Now, buoyed by that success, activists are applying
the same strategy to a fresh wave of hepatitis C drugs. They note that
the standard 12-week course of treatment costs more than the average
annual salary for millions of people in middle-income countries.
Public-health
experts say that expanding access to the drugs would have immediate
benefits. Roughly 177.5 million adults worldwide are infected with the
hepatitis C virus, which can cause liver cancer and cirrhosis if left
untreated — but the latest antiviral medications have revolutionized
care. The first to reach the market was sofosbuvir, sold under the name
Sovaldi by Gilead Sciences of Foster City, California; clinical trials
of the drug in combination with other medications have shown a cure rate
of 95% or more. “If these medicines were made widely available, you
could make a plan to eliminate this disease,” says Brook Baker, a law
specialist at Northeastern University in Boston, Massachusetts.

As
the world’s main supplier of generic drugs, India is at the centre of
the current patent fight. Patient advocates celebrated when the
country’s patent office rejected Gilead’s application for a basic patent
on sofosbuvir in January 2015, on the grounds that it was not
scientifically inventive enough to warrant exclusivity, despite its
clear medical advantages. But an Indian court overturned the decision
last May — and that verdict in turn is now being contested.
Four
of the lawsuits filed in February target other Indian patents on
sofosbuvir and two related drugs, Gilead’s velpatasvir (sold in
combination with sofosbuvir under the name Epclusa) and Daklinza
(daclatasvir) from Bristol-Myers Squibb in New York City. The fifth
challenges Gilead’s application to patent sofosbuvir in Argentina.
“The
science behind sofosbuvir doesn’t merit these patents,” says Tahir
Amin, director of the Initiative for Medicines, Access and Knowledge in
New York City. The activist group is involved in a dozen ongoing
lawsuits related to patents for hepatitis C drugs — including the cases
in India and Argentina, and others in Brazil, the European Union, Egypt
and Ukraine.

“This battle is about trying to ensure that Gilead has the shortest possible monopoly.”

Some of the suits argue that sofosbuvir,
velpatasvir and daclatasvir are not sufficiently inventive to warrant a
patent. Others challenge Gilead’s attempts to obtain additional patents
on sofosbuvir by modifying it slightly, to extend the company’s
intellectual-property rights — a practice called evergreening. “This
battle is about trying to ensure that Gilead has the shortest possible
monopoly,” says Leena Menghaney, who runs a drug-access campaign in
South Asia for the charity Médecins Sans Frontières, which is supporting
the lawsuits.
Gilead notes that it has taken
steps to reduce the cost of its antiviral medications for hepatitis C —
offering tiered pricing for sofosbuvir and other drugs, on the basis of
factors such as a nation’s economic status and the volume of medicine
that it requires. The list price for a 12-week course of sofosbuvir is
US$84,000 in the United States, $50,000 in Turkey and Canada, about
$6,000 in Brazil and just $900 in Egypt.
Gilead
has also licensed 11 manufacturers in India to produce cheaper generic
versions of its hepatitis C drugs for sale in 101 developing countries.
The generic medications retail for $300–$900 per treatment course in
countries where they are permitted; in return, Gilead receives a 7%
royalty payment to keep its access-to-medicines programme running.
This
system draws on lessons that Gilead learnt during lawsuits and protests
over access to HIV medications in the early 2000s, says Clifford
Samuel, Gilead’s senior vice-president of access operations and emerging
markets. “We got a tremendous amount of criticism in the early days of
our HIV programme, and it refined us,” he says.
But
that does not appease Amin, who says that Gilead’s deals with
generic-drug manufacturers do not reduce the cost of its hepatitis C
medications in middle-income countries. One analysis published last year
found that sofosbuvir and related drugs are too pricey for those
nations (S. Iyengar et al. PLoS Med. 13, e1002032; 2016).
Using these drugs to treat every person infected with hepatitis C in
Poland would cost 1.6 times the country’s annual expenditure on
medicines for all conditions. The price of one course of treatment is
equal to about six years of earnings for the average Pole.
Gilead
intends to protect its patents in high- and middle-income countries,
while working to improve access to drugs through discounts and tiered
pricing. “We need revenue to put back into the development of drugs for
other diseases,” Samuel says.
The company has
already recouped its original investment in sofosbuvir. It acquired the
drug in 2011 when it bought Pharmasset, a biotechnology company in
Princeton, New Jersey, for $11.2 billion. Since sofosbuvir hit the
market in 2014, the drug and two similar medications have earned Gilead
$46 billion.
Menghaney expects the first
hearings in the new wave of patent lawsuits to come in six months to a
year. But she’s already looking to new frontiers. “I hope these battles
in developing countries lead people to challenge weak patents and
evergreening patents in the United States,” she says.